Carlsmed gets FDA breakthrough device status for aprevo technology
21 Sep 2023
Breakthrough Therapy
According to the medical device maker, the customised aprevo devices are 3D printed and sterile packed and are directly delivered to hospitals for surgeries
The aprevo technology is intended for patients with cervical spine disease. (Credit: Kenny Eliason on Unsplash)
Carlsmed has received the breakthrough device designation from the US Food and Drug Administration (FDA) for its aprevo technology to treat patients with cervical spine disease.
The US-based medical device maker designed the aprevo personalised surgery platform with the goal of improving the quality of care for each individual undergoing spine surgery.
The digital technology platform is intended to create unique fusion devices tailored for each patient.
According to the medical device maker, the customised aprevo devices are 3D printed and sterile packed. They are directly delivered to the hospital for surgery.
Carlsmed CEO Mike Cordonnier said: “Our goal is to accelerate deployment of patient-centric pioneering technology that revolutionises the standard of care for spine surgery.
“Expanding the application of our personalised solutions to help patients suffering from cervical spine disease is the next natural step for our portfolio.”
The aprevo technology represents Carlsmed’s second breakthrough device designation.
It joins the medical device company’s range of lumbar patient-specific interbody fusion devices for anterior, lateral, and transforaminal approaches.
California-based UCSF Medical Center spinal tumour and spinal deformity surgery director Christopher Ames said: “Maintenance of sagittal balance after anterior cervical discectomy and fusion procedures is an important parameter to reduce risk for subsequent degeneration at adjacent levels.
“Using aprevo personalised interbody devices in conjunction with careful preoperative planning for cervical procedures may help surgeons more reliably achieve the optimal alignment for each individual patient.”
The aprevo device for cervical spine disease treatment is expected to be rolled out in the US in 2025.
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